EP2609937B1 - Hydrogen peroxide container and delivery system - Google Patents

Hydrogen peroxide container and delivery system Download PDF

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Publication number
EP2609937B1
EP2609937B1 EP13158399.9A EP13158399A EP2609937B1 EP 2609937 B1 EP2609937 B1 EP 2609937B1 EP 13158399 A EP13158399 A EP 13158399A EP 2609937 B1 EP2609937 B1 EP 2609937B1
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EP
European Patent Office
Prior art keywords
hydrogen peroxide
container
needle
stand
delivery system
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
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EP13158399.9A
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German (de)
English (en)
French (fr)
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EP2609937A1 (en
Inventor
Bruno Tremblay
Jean-Martin Vallières
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Technologies of Sterilization with Ozone TSO3 Inc
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Technologies of Sterilization with Ozone TSO3 Inc
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Publication of EP2609937A1 publication Critical patent/EP2609937A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/202—Ozone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/208—Hydrogen peroxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/24—Apparatus using programmed or automatic operation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D23/00—Details of bottles or jars not otherwise provided for
    • B65D23/001—Supporting means fixed to the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/122—Chambers for sterilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/13—Biocide decomposition means, e.g. catalysts, sorbents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • the present invention relates generally to sterilization apparatus. More particularly, the present invention relates to a hydrogen peroxide delivery system for a sterilization apparatus using gaseous hydrogen peroxide under vacuum.
  • Sterilization is the destruction of any virus, bacteria, fungus or other microorganism, whether in a vegetative or in a dormant spore state and is defined by a 10 -6 reduction in the level of bacteria.
  • Conventional sterile processing procedures for medical instruments involve high temperature (such as steam and dry heat units) or chemicals (such as ethylene oxide gas, hydrogen peroxide, or ozone).
  • Sterilization methods and apparatus using gaseous sterilants are well known.
  • Sterilizers using hydrogen peroxide as the sterilant are widely used.
  • the hydrogen peroxide is generally supplied as an aqueous solution and evaporated prior to injection into a sterilization chamber of the sterilizer, by heating of the solution, or by applying a vacuum to the sterilization chamber, or both.
  • the sterilization atmosphere in the sterilization chamber includes water vapor and hydrogen peroxide gas. It is a disadvantage of this process that the water vapor tends to condensate on articles in the chamber as the sterilization proceeds. The resulting layer of water condensate on the articles to be sterilized interferes with the sterilizing action of the hydrogen peroxide.
  • Numerous apparatus and process modifications have been developed to address this problem, all of which are aimed at limiting the relative humidity in the sterilization atmosphere during the sterilization process. However, these modifications invariably increase operating cost and/or sterilization cycle times.
  • Sterilizers using ozone containing gas as the sterilant are also known.
  • the ozone gas is generally produced externally to the sterilization chamber and supplied into the chamber under vacuum to increase penetration of the sterilant gas into restricted spaces on the articles to be sterilized.
  • the sterilization atmosphere is generally humidified with water prior to the injection of ozone gas into the sterilization chamber.
  • the amount of ozone gas needed is relatively high (85mg/l) and the sterilization cycle times are relatively long, making ozone based sterilization processes comparatively expensive.
  • many articles to be sterilized are damaged by the high levels of ozone required to achieve complete sterilization and can therefore not be sterilized in an ozone sterilization process.
  • Sterilization processes using both hydrogen peroxide gas and ozone gas have been used, but with unsatisfactory results especially with respect to the sterilization of articles with long internal lumens, such as gastroscopes and colonoscopes, and with respect to cycle times and sterilization cost.
  • ozone based processes are satisfactory with respect to sterilization of articles with long lumens, material compatibility represents a problem.
  • Hydrogen peroxide based processes are generally unsatisfactory regarding the sterilization of long lumens.
  • a hydrogen peroxide delivery system for a sterilizer is known from EP 1 177 986 A1 .
  • That prior art hydrogen peroxide delivery system comprises a removable sterilizing agent capsule container. Hydrogen peroxide capsules and air capsules are alternately stacked in the capsule container.
  • the lowest sealed capsule is supported by a capsule support which has an insert hole through which a drainage needle can pass in order to puncture the under part of the lowest sealed capsule.
  • the drainage needle is arranged to be vertically lifted in two steps corresponding to the locations of the vertically stacked capsules. In the first step the needle is lifted to a position where it punctures the under part of the lowest capsule. In the second step the needle passes through the deflated lowest capsule to a position where it punctures the under part of the next sealed capsule.
  • Hydrogen peroxide solution from the punctured capsule passes through the needle to an evaporator in a sterilizing chamber.
  • the air capsules alternately stacked between the hydrogen peroxide solution capsules serve to exert pressure on the hydrogen peroxide oxide capsule actually punctured by the needle in order to force hydrogen peroxide solution to pass through the needle.
  • its capsule is gradually deflated, and the adjacent air capsule in the stack increasingly expands corresponding to the deflation to continue pressurizing.
  • US 4,548,348 A discloses a container comprising a hollow body with a top end, a tapered side wall and a flat bottom, a cup-shaped stand supporting the container and providing thermal isolation, and a connecting arrangement including an external recess in the side-wall of the hollow body and a radially inwardly extending rib in the stand for engagement with the recess to provide a snap-fit connection.
  • That prior art container is a disposable cup assembly used for offering hot beverages such as coffee, tea or hot chocolate, and there is no hint in US 4,548, 348 A that the disposable cup assembly could be adapted for using as a hydrogen peroxide solution container for use in the delivery system of a sterilizer.
  • the disclosure provides a hydrogen peroxide delivery system for a sterilizer which sterilizer has a hydrogen peroxide injection unit and a housing
  • said hydrogen peroxide delivery system includes a cradle for supporting a sealed hydrogen peroxide solution container in an upright position within the housing, a drainage arrangement connected with the cradle for aspirating the hydrogen peroxide solution from the container and to be connected to the hydrogen peroxide injection unit of the sterilizer for supplying the aspirated hydrogen peroxide solution to the hydrogen peroxide injection unit of the sterilizer.
  • the drainage arrangement includes a drainage needle for penetrating a seal on the container and extending into the hydrogen peroxide solution in the container, and a reciprocatable needle drive for moving the needle from an at rest position, wherein the needle is retracted to allow insertion of a new hydrogen peroxide container into the cradle, to a penetrating position wherein the needle penetrates the seal of the container and extends into the hydrogen peroxide solution in the container.
  • the needle extends all the way to a bottom of the container in the penetrating position; and a control structure for ensuring contact of the needle with the bottom of the container while preventing penetration of the bottom of the container.
  • the hydrogen peroxide delivery system comprises a reservoir connected with the drainage arrangement for supplying the hydrogen peroxide solution to the hydrogen peroxide injection unit of the sterilizer, wherein the drainage needle of the drainage arrangement is connected with the reservoir.
  • the disclosure provides a hydrogen peroxide delivery system, wherein the container includes a stand for supporting a hydrogen peroxide solution container in an upright position within the housing.
  • the delivery system of the present disclosure uses a hydrogen peroxide solution container with a conical bottom to ensure complete drainage of all liquid in the container by a drainage needle of a delivery system, whereby the conical bottom of the container is centered with an axis of the drainage needle for aligning a tip of the needle with the lowest point of the bottom.
  • the present disclosure provides a sealed hydrogen peroxide solution container including a hollow body with a top end including a sealed fill and drainage opening, a side wall and a conical bottom, a stand for maintaining the container in an upright position on a flat horizontal surface prior to insertion into the cradle and a connecting arrangement for connecting the stand to the body, whereby the bottom of the container is conical to ensure any residual hydrogen peroxide solution collects at a lowest point of the bottom.
  • the stand is snap fitted onto the hollow body.
  • the container includes an external recess in the side wall of the body and the stand is cup-shaped and has a radially inwardly extending tab for engagement with the recess to provide a snap fit connection of the stand to the body.
  • the recess is a circumferentially extending, continuous groove and the stand includes at least two tabs for engagement of the groove.
  • the present disclosure provides a hydrogen peroxide delivery system for use in methods and systems for sterilization of an article in a sterilization atmosphere by adding evaporated hydrogen peroxide.
  • the delivery system can be used, for example, in a method of sterilizing an article by exposure to hydrogen peroxide and ozone, as illustrated in the flow diagram of FIG. 3 and the cycle graphs of FIG.s 4 to 6 .
  • the article is exposed under vacuum first to an evaporated aqueous solution of hydrogen peroxide and subsequently to an ozone containing gas.
  • the sterilization process is achieved while the chamber remains sealed and under vacuum.
  • the chamber is initially evacuated to a first vacuum pressure sufficient to cause evaporation of the aqueous hydrogen peroxide at the temperature of the chamber atmosphere.
  • the chamber is then sealed and hydrogen peroxide and ozone containing gas are sequentially added to the chamber and maintained in the chamber for a preselected exposure time. All removal of any components in the sterilization atmosphere is stopped during addition of the sterilants and for the duration of the exposure time.
  • the aqueous hydrogen peroxide solution is evaporated and directly injected into the sterilization chamber without any measures to reduce the water vapor content.
  • the delivery system can be used in an exemplary sterilizer as illustrated schematically in FIG. 1 , which sterilizer operates generally in the following manner.
  • An article to be sterilized (not shown) is placed into a sterilization chamber 10 and the chamber is sealed.
  • a vacuum is applied to the chamber 10.
  • Evaporated hydrogen peroxide solution is supplied into the sterilization chamber 10 from a delivery unit 30 (see FIG. 8 ), which will be discussed in more detail below.
  • the evaporated hydrogen peroxide supplied into the chamber provides a partial sterilization of the article.
  • Medical quality oxygen is subjected in an ozone generator 22 to an electrical field, which converts the oxygen into ozone containing gas.
  • the ozone containing gas is then fed into the chamber 10, which has been humidified by the injection of the evaporated hydrogen peroxide solution and the decomposition of the hydrogen peroxide into free radicals (hydroxyls), water and oxygen.
  • the ozone containing gas finishes the sterilization of the article. Remaining sterilant gases are subsequently decomposed into water and oxygen using a catalyst 52. The only residues left at the end of the sterilization cycle are oxygen and clean water.
  • a delivery system in accordance with the present disclosure allows for a hydrogen peroxide sterilization method to be carried out without the handling of dangerous gas cylinders, and poses no threat to the environment or the user's health.
  • FIG. 1 An exemplary sterilization apparatus in connection with which the delivery system of the present disclosure can be used is illustrated schematically in FIG. 1 .
  • the exemplary apparatus includes a sterilization chamber 10 which can be sealed to contain a vacuum. This is achieved with an access door 12, which can be selectively opened for access into the chamber and which seals the chamber in the closed condition.
  • the apparatus further includes an ozone generator 22 for supplying ozone-containing gas to the sterilization chamber, a hydrogen peroxide delivery unit 30 for supplying evaporated hydrogen peroxide to the sterilization chamber 10, and a vacuum pump 40 (CM-005-052 TSO3, Inc.).
  • the vacuum pump 40 is used for the application of a sufficient vacuum to the sterilization chamber 10 to increase the penetration of the sterilizing gas and to be able to generate evaporated hydrogen peroxide solution at a temperature below the temperature inside the sterilization chamber.
  • the vacuum pump 40 in the preferred embodiment is capable of producing a sufficient vacuum in the sterilization chamber to lower the boiling point of water in the chamber below the actual temperature of the atmosphere in the chamber.
  • the vacuum pump is capable of producing a vacuum of 1 Torr (1.33mbar).
  • the gas can be heated for a preselected time to a temperature at which the sterilant decomposition is accelerated, for example, to 300°C for a period of 3 seconds.
  • the hydrogen peroxide delivery unit 30 includes a reservoir 220 (AM-213-010, TSO 3 Inc.), a metering unit 240, and an evaporator unit 260 (FM-213-003, TSO 3 Inc.) directly connected to the sterilization chamber 10 through a conduit 280. (AM-213-003, TSO 3 Inc.)
  • the reservoir 220 is equipped with a level sensor 222 to always ensure a sufficiently high level of hydrogen peroxide for the execution of another sterilization cycle.
  • a hydrogen peroxide solution (3-59%) is supplied to the reservoir from a hydrogen peroxide supply unit 200 (see FIG. 7 ), which will be discussed in more detail below.
  • the hydrogen peroxide solution is supplied into the supply unit 200 from a sealed hydrogen peroxide solution container, in this embodiment a bottle 180 (see FIG. 7 ).
  • the evaporated hydrogen peroxide solution produced in the evaporator unit 260 directly enters the sterilization chamber 10 with no intermediate flow restriction or valve.
  • the evaporator unit is preferably equipped with a heating device (not shown) that maintains the temperature of the hydrogen peroxide solution sufficiently high to achieve a higher evaporation rate and prevent freezing of the solution.
  • the ozone generator 22 (OZ, model 14a, TSO 3 Inc.) is of the corona discharge type and is cooled to decrease the ozone decomposition rate, all of which is well known in the art.
  • the vacuum in the sterilization chamber 10 is produced by way of the vacuum pump 40 and the sterilization chamber drainage valve 44.
  • Valves 29a and 29b are Teflon solenoid valves (CM-900-156, TSO3 Inc.) Valve 26 and vacuum valve 44 are solenoid valves (CM-015-004, TSO3 Inc.).
  • the preferred ozone generator used in the process and apparatus of the invention is a generator of the corona discharge type, which is well known to the person skilled in the art and need not be further described herein.
  • An exemplary sterilization method includes the following general steps as illustrated by the flow chart of FIG. 3 .
  • Articles to be sterilized such as medical instruments, can be placed directly into the sterilization chamber, but are preferably sealed in sterile packaging containers, sterile wraps or pouches such as generally used in the hospital environment and then placed into the sterilization chamber.
  • the door of the sterilization chamber is closed and the chamber sealed in step 340 and a vacuum is applied to the sterilization chamber in step 350 until a first pressure of 1 Torr (1.33 mbar) is reached in the chamber.
  • the sterilization chamber walls have preferably been preheated in a warm-up step 310 to a temperature of 40°C.
  • Evaporated hydrogen peroxide solution is admitted into the sterilization chamber in humidification step 360 to partially sterilize and humidify the chamber contents. The injection of evaporated hydrogen peroxide solution is stopped once a pressure increase of 19 Torr has been achieved in the chamber.
  • the chamber can be maintained sealed for a first exposure period 370 (preferably 2 minutes) during which the hydrogen peroxide at least partially decomposes into free radicals, water and oxygen. This exposure period can also be omitted.
  • An ozone containing gas preferably in the form of a mixture of dry ozone and oxygen is then supplied to the chamber in the ozone injection step 380 and the chamber maintained sealed for a preselected second exposure period 390. No humidification of the ozone containing gas is carried out, or is even necessary, since the chamber atmosphere has been humidified by the hydrogen peroxide solution.
  • a ventilation phase 400 is commenced, which preferably includes multiple cycles of evacuation of the chamber and flushing with oxygen.
  • the door is unlocked in step 410 and the sterilized articles can be taken from the chamber.
  • the temperature of the floor and door of the chamber and of the evaporator unit is preferably controlled throughout the sterilization process.
  • the user has the choice of multiple different sterilization cycles.
  • the user can choose in cycle selection step 330 of the process among three cycles which have the respective characteristics shown in Table 1 and discussed below.
  • Table I Cycle phases Cycle 1 Cycle 2 Cycle 3 Vacuum 1 Torr 1 Torr 1 Torr Humidification with 50% H202 solution 20 Torr 20 Torr 20 Torr Humidification plateau (optional) 2 min 2 min 2 min 03 Injection 2 mg/1 10 mg/L 3 mg/L Exposure 5 min 5 min 10 min Nb of repetition(s) 2 2 4 Approx. Cycle duration 46 min 56 min 100 min
  • Cycle 1- Surface sterilization of devices having low compatibility with ozone, hinged devices and short flexible endoscopes (1 mm x 85 cm). (Ex. Cameras, cables, paddles, forceps, bronchoscopes, ureteroscopes).
  • Cycle 2- Surface devices with high compatibility with ozone, hinged instruments and rigid endoscopes (1 mm x 50 cm).
  • Cycle 3- Instruments sterilizable with cycle #1 and complex endoscopes (Ex. gastroscopes, colonoscopes).
  • the process can be operated with solutions including 3% -50% hydrogent peroxide.
  • Exemplary conditions for the process when operated with a 3%, 30% and 50% hydrogen peroxide solution are as follows. Table II % H 2 O 2 Max Injection Pressure (Torr) Ozone dose (mg/L) No of repetitions Conditioning time 3 44-54 25-50 2-8 2 hrs 30 30-44 5-25 2-6 2 hrs 50 17-21 (20) 2-10 2-4 0 hr
  • the maximum injection pressure is the pressure at which injection of the evaporated hydrogen peroxide solution is stopped.
  • the conditioning time represents a time period after sealing of the chamber and prior to application of the vacuum in which the articles to be sterilized are maintained in the sterilization chamber and gradually warm up from room temperature due to the chamber walls, floor and door being heated to about 40°C. This warming up of the load in the chamber is required to prevent undue condensation of water on the load on injection of the evaporated hydrogen peroxide solution. The risk of condensation increases with decreasing hydrogen peroxide solution concentrations.
  • the sterilizer control system (see FIG. 9 ) will then, under the control of a built in operating software, start the sterilization process according to the cycle chosen and using preselected parameters for the cycle chosen.
  • the cycle starts with the generation of a vacuum in the sterilization chamber of approximately 1 Torr (1.33mbar).
  • An evaporated aqueous hydrogen peroxide solution is subsequently injected into the chamber through the evaporator unit to partially sterilize and humidify the load.
  • the hydrogen peroxide solution passes through the metering unit 240 shown in FIG. 8 .
  • the metering unit 240 is directly connected to the evaporator unit 260 and, thus, subjected to the vacuum pressure present in the chamber.
  • the metering unit 240 includes a base block 241 having a passage of a fixed, known volume (not shown) and connected by an intake valve 242 at an upstream end of the passage to the hydrogen peroxide reservoir 220 and by an exhaust valve 243 at a downstream end of the passage to the evaporator unit 260.
  • the flow of hydrogen peroxide solution through the metering unit 240 can be exactly controlled by way of the valves 242, 243, which are switched oppositely and nonoverlapping so that one valve is always closed when the other is open and both valves are never open at the same time.
  • the passage is evacuated when the exhaust valve 243 is open and the intake valve 242 is closed, filled with hydrogen peroxide solution when the exhaust valve 243 is closed and the intake valve 242 is open and evacuated again when the exhaust valve 243 is again open and the intake valve 242 is again closed. Since the exact volume of the passage is known, the amount of hydrogen peroxide solution supplied per valve cycle is known and the total amount of hydrogen peroxide can be calculated on the basis of the number of valve switching cycles.
  • valves 242, 243 open and close are controlled and monitored by apparatus software and can be used to determine the amount of hydrogen peroxide solution removed from the reservoir and to calculate the theoretically remaining amount of solution in the reservoir, based on the total amount aspirated from the supply bottle and the metered amount.
  • the hydrogen peroxide delivery system 200 of this disclosure intended for a sterilizer having a hydrogen peroxide injection unit and a housing, includes a bottle holder or cradle 202 for supporting a sealed hydrogen peroxide solution container 180 in an upright position within the housing (not shown), a drainage arrangement 207 connected with the cradle for aspirating the hydrogen peroxide solution from the container 180, and a delivery arrangement connected with the drainage arrangement for supplying the aspirated hydrogen peroxide solution to the hydrogen peroxide injection unit.
  • the drainage arrangement 207 includes a drainage needle 209 connected with the delivery arrangement for penetrating a seal on the container 180 and extending into the hydrogen peroxide solution in the container, and a needle drive 208 for moving the needle from an at rest position, wherein the needle is retracted to allow insertion of a new hydrogen peroxide container into the cradle, to a penetrating position wherein the needle penetrates the seal of the container and extends into the hydrogen peroxide solution in the container. In the penetrating position, the needle preferably extends all the way to a bottom of the container.
  • the delivery system includes a bottle holder for receiving a sealed hydrogen peroxide solution bottle 180.
  • the holder has a bottle seat or cradle 202 in which the bottle 180 is fittingly received.
  • the bottle 180 which will be discussed in more detail further below, is held in the seat 202 by gravity only.
  • the holder is rotatably mounted on pivot 203 for movement between an open position as illustrated in FIG. 7 , which the bottle 180 can be placed into or removed from the holder and a closed position in which the holder is completely within the sterilizer cabinet or housing (not shown) and a front cover 205 of the holder closes off all access to the holder from outside the cabinet.
  • a pneumatically driven drainage arrangement 207 including a needle drive, in this embodiment a vertically oriented pneumatic cylinder 208, and a drainage needle 209 mounted on the piston rod 210 of the cylinder, is activated to drain all hydrogen peroxide solution from the bottle 180. This is achieved by activating the cylinder 208 to force needle 209 through the bottle seal until the needle tip reaches the bottom of the bottle 180.
  • the needle 209 is fluidically connected to the reservoir 220 (see FIG. 8 ) and the solution is aspirated from the bottle 180 and into reservoir 220 by using the vacuum generated by the vacuum pump 44 to which the reservoir 220 can be fluidically connected by conduit 211 and valve 212 (see FIG. 1 ).
  • the holder can be opened and the bottle removed, or the empty bottle can be kept in the holder until a refill of the reservoir 220 is required.
  • the reservoir 220 is provided with a level sensor 222 which provides a signal to the control system on the liquid level in the reservoir. Based on the signal received from the sensor 222, the control system notifies the user if the amount of liquid in the reservoir 220 is insufficient for the execution of the cycle selected by the user.
  • the hydrogen peroxide delivery system does not include a reservoir. Instead, the bottle 180 itself is cooled down (CS-01) to avoid rapid degradation of the aqueous hydrogen peroxide.
  • a sensor measures the amount of solution left in the bottle. When the solution reaches a 1 st preselected level, a 1 st warning appears on the screen and when a lower, 2 nd preselected level is reached, the message generated from the software to the operator specifies that only one more sterilization cycle #1 or #2 can be run with the remaining solution in the bottle. The operator will then have to reload the delivery system with a fresh, full bottle.
  • the bottle 180 has a conical bottom 182 to ensure a complete drainage of all liquid in the bottle, thereby reducing the danger of spills or contamination on removal of a drained bottle.
  • a stand 184 is attached to the bottom end of the bottle.
  • the stand 184 includes an upturned cup 185 snap fitted into a circumferential groove 186 on the bottle exterior wall 187.
  • the needle 209 is aligned with the lowest point in the bottle bottom and can be moved into the bottle, through the bottle seal, until it reaches the lowest point in the bottle.
  • Mechanical, electronic or other control structures and functions are provided to ensure contact of the needle with the bottle bottom while preventing penetration of the bottle bottom.
  • a pressure sensor is preferably incorporated into the needle drive and/or the needle mount (not shown).
  • the needle drive is reciprocatable for moving the needle back and forth between the at rest and penetrating positions, whereby in the at rest position the needle is retracted to allow insertion of a new hydrogen peroxide container and in the penetrating position the needle penetrates the seal of the container and extends into the hydrogen peroxide solution in the container all the way to the bottom of the container.
  • the control system could be used for both systems.
  • the first system depicted in the present application in Fig 7 and Fig 8 is mainly a bottle of H2O2 (180) flushed into a temperature controlled reservoir (220) Fig 8 .
  • This first system will be described with reference to FIG.s 7 , 8 , 9 and 2 . All input and output sensors described in the following appear in the list of inputs and outputs of the control system listed on Fig 9 .
  • FIG. 9 reads a bar code on the bottle.
  • the CPU verifies the expiry date of the bottle and if the bottle is past its expiry date, the door 205 remains unlocked and a message on the screen (118) invites the user to change the bottle for another one. If the date is correct, the CPU stops the motor M-02 and locks the door (205) by actuating PA-02 ( Fig 2 ). Then CPU actuates the cylinder (208) for the needle 209 to perforate the sealed cap of the bottle until S9 senses the needle in the down position. Then the bottle is totally emptied into the reservoir 220 by suction provided through valve (212) and vacuum from pump (40).
  • Level sensors S10 and S11 provide the conditions necessary for the CPU to estimate if another bottle is needed. If so, the needle is retracted from the bottle and the door (205) is unlocked and the user is invited by a message on the screen (118) to replace the H2O2 bottle.
  • the following dispensing system does not include the cooled reservoir (220). Instead, the H2O2 remains in the bottle (180).
  • Level detectors S10 and S11 are removed and replaced by an ultrasonic level detector which is spring loaded against a side of the bottle near the bottom and used as a low level detector to indicate to the CPU an empty bottle. Because this sensor is spring loaded, it adds too much friction on the bottle to use the motor M-02. Therefore, the user is invited by a message on the screen (118) to rotate the bottle manually until the bar code is read by (BS-01) Fig 2 or (122) fig 9 . If the bottle is not out of date, the user is invited to close the door (205) and the CPU locks the compartment of the bottle holder and actuates (208) to puncture down the needle.
  • the H2O2 holder is temperature controlled by a Peltier cell unit.
  • An RTD attached to the holder and connected to the temperature interface (121) sends data to the CPU (108) by Device Net network and the CPU controls by PID function the amount of power being applied to the Peltier cell unit.
  • the Peltier unit is supplied by the 12VDC (121) power supply used also for the air compressor driving the pneumatic system composed of SV-15, SV-16, actuators (PA-02 and PA-01) on Fig 2 .
  • the line connected between the H2O2 bottle (180) and micro valve module (240) will be purged by SV20. Near the inlet of module (240) a foam optical detector snapped on the H2O2 line will indicate the total refill of the line without air in the line.
  • both H2O2 dispensing systems can supply the micro valves module (240).
  • the micro valves (SV-18 and SV19) are working reciprocally for a preset duty cycle program on an on board microcontroller circuit generating the proper timing pulses for both micro-valves. That electronic circuit is activated by a signal from the CPU (108) called H2O2 pump controller signal FIG 9 .
  • H2O2 pump controller signal FIG 9 Under software control, a proper amount of H2O2 is allowed in the humidifier manifold (260, Fig1 ). This manifold is temperature controlled by the CPU (108) using data of RTD (TT-04, Fig. 1 ) and controlling heater HTR-01 ( Fig. 1 ) by PID function.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Feeding, Discharge, Calcimining, Fusing, And Gas-Generation Devices (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
EP13158399.9A 2009-09-30 2010-09-29 Hydrogen peroxide container and delivery system Not-in-force EP2609937B1 (en)

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EP16160873.2A Not-in-force EP3056224B1 (en) 2009-09-30 2010-09-29 Sterilization method
EP13158378.3A Not-in-force EP2601976B1 (en) 2009-09-30 2010-09-29 Hydrogen peroxide sterilization method
EP10819766.6A Not-in-force EP2482859B1 (en) 2009-09-30 2010-09-29 Sterilization method
EP13158395.7A Not-in-force EP2601979B1 (en) 2009-09-30 2010-09-29 Sterilisation method
EP13158399.9A Not-in-force EP2609937B1 (en) 2009-09-30 2010-09-29 Hydrogen peroxide container and delivery system
EP20130158381 Not-in-force EP2601977B1 (en) 2009-09-30 2010-09-29 Hydrogen peroxide metering method
EP13158388.2A Not-in-force EP2601978B1 (en) 2009-09-30 2010-09-29 Hydrogen peroxide metering method
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EP13158378.3A Not-in-force EP2601976B1 (en) 2009-09-30 2010-09-29 Hydrogen peroxide sterilization method
EP10819766.6A Not-in-force EP2482859B1 (en) 2009-09-30 2010-09-29 Sterilization method
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EP20130158404 Not-in-force EP2601980B1 (en) 2009-09-30 2010-09-29 Hydrogen peroxide metering unit

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